FIELD: medicine, pharmaceutics.
SUBSTANCE: group of inventions refers to medicine and concerns a method for preparing a spray-dried stable powder composition containing an antibody or its antigen-binding fragment; a pharmaceutical preparation containing an effective amount of the spray-dried stable powder composition containing the antibody or its antigen-binding fragment and prepared by the method described above; the spray-dried stable powder composition prepared by the method described above, containing the antibody or its antigen-binding fragment, and an excipient, wherein the composition contains residual moisture of 6% or less and the antibody or its antigen-binding fragment is specified in a group consisting of MAK 195F, ABT-325, ABT-308 or ABT-147.
EFFECT: group of inventions provides preparing the spray-dried high-stability powder composition.
44 cl, 11 dwg, 14 tbl
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